The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a licence extension for Amgen’s Blincyto (blinatumomab), expanding its use in acute lymphoblastic leukaemia (ALL). This immunotherapy is now approved for adults with Philadelphia chromosome-negative (Ph-) CD19-positive B-cell precursor ALL during the consolidation phase of frontline treatment. This phase aims to eliminate any remaining leukaemia cells after initial remission.
Key details include:
- ALL in the UK: Around 300 new adult cases are diagnosed annually, with B-cell ALL being the most common subtype, representing 75% of cases. Despite high remission rates post-induction therapy, relapse remains a significant risk, highlighting the need for improved targeted treatments.
- Mechanism of Blincyto: A bispecific T-cell engager (BiTE), Blincyto connects T cells to CD19 antigens on B cells, facilitating targeted immune responses.
- Clinical Evidence: The approval is based on the positive findings of the E1910 trial by ECOG-ACRIN Cancer Research Group, which demonstrated improved overall survival (OS) and relapse-free survival (RFS) when Blincyto was added to multiphase consolidation chemotherapy compared to chemotherapy alone.
This decision aligns with the FDA’s approval of Blincyto for the same indication in June, underscoring its potential to address unmet needs in the management of ALL.